Wednesday, October 03, 2007

Behind the counter meds

Everyone has heard about over-the-counter medications. You just walk into your local pharmacy, look around for your favorite cough/cold medicine, or stomach medicine, or pain medicine, or whatever. You take it off the shelf, go to the register, and that's it.

And, everyone is familiar with prescription drugs. You visit your favorite physician, have the appropriate interview and physical exam, receive the prescription, and then go to your local pharmacy to have the prescription filled.

Now, the FDA is looking at what is being called "behind-the-counter" medications. What the heck are they talking about? (With the FDA, sometimes it's difficult to figure out what they are talking about sometimes.) In this Associated Press article, they try to explain what the FDA is looking for.

"Behind-the-counter" sales offer a middle ground. Last year, the FDA allowed the emergency contraceptive Plan B, also called the morning-after pill, to be sold without a doctor's note to women 18 and older — but only by pharmacies that checked women's photo identification before handing over the pills. Minors still require a prescription.

Now the question is whether requiring additional interaction with a trained pharmacist — health advice or even, say, a blood pressure or cholesterol check — might further spur the evolution of nonprescription drugs from quick symptom relief to more complex therapy.

Routine birth control pills are an often-cited candidate. And in 2005, the FDA rejected a bid to sell cholesterol-lowering Mevacor without a prescription — although some of the agency's scientific advisers said such a move might one day be possible if pharmacists could help guide which customers bought the pills.

Now, as far as behind the counter medicines go now, there are certain cough/cold medications which are not OTC (ie - pseudoephedrine containing medications), apparently because of federal law and state law.

However, I think what the FDA is talking about here is distinctly different. I remember a couple of years ago when there was talk about making cholesterol medications available without a prescription. Even though this is done in Britain, I still don't think that it would be a good idea to do that in this country. I believe physician oversight is essential for a situation like this.

The FDA has to be very careful about looking at which medications they are considering to be behind the counter. Giving advice on certain medications and then dispensing them as a pharmacist is one thing. But, then, potentially taking the next step and evaluating/treating a patient for things like elevated cholesterol is something else. This is practicing medicine in my book.

3 comments:

I remember when I was young you could get cough syrup made of turpin hydrate and codeine (or was it "turpen"?) if you signed for it with the pharmacist. Of course now anything with codeine is prescription only as far as I know.

I agree with you that I don't think cholesterol-lowering drugs should be "behind the counter." Too many people would try to take them without any oversight and since these drugs can cause liver problems and other hazardous conditions, regular blood tests and checkups should be a part of the treatment. Not everyone is a candidate for these drugs. And if my local CVS is any indication, I don't have a lot of faith that the pharmacists there, who seem to spend 99% of their time filling prescriptions by moving pills from one bottle to another, would have the time to discuss treatments with each patient that requested Mevacor.

Ditto on birth control pills - a morning after pill is one thing - it's, hopefully, a one-time use; but taking b.c. pills for long periods of time can be dangerous for the wrong people, what with blood clots and high blood pressure being side effects for some.

This makes sense for things like sumitriptan or albuterol - medications to abort chronic/episodic conditions where light use is unproblematic but regular use should ring alarm bells and proper prophylactic medications instigated. a mechanism whereby people could obtain occasional (say one pack every 6 months) supplies of medications for immediate attacks yet their total consumption is monitored somehow (say with an emergency medications card that pharmacists can write to and is difficult to get multiple ones of) would reduce the number of people needing to see doctors urgently for simple treatment.